AbbVie ABBV announced that a phase III study evaluating its oral JAK inhibitor, Rinvoq (upadacitinib) in patients with moderate-to-severe atopic dermatitis (“AD”) met both primary endpoints and all secondary endpoints.
The phase III study — Measure Up 2 — evaluated two doses of Rinvoq monotherapy (15/30 mg) in AD patients for improvement in the Eczema Area Severity Index (EASI 75) from baseline and a validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0/1 (clear or almost clear) at week 16 as primary endpoints. A key secondary endpoint was improvement in Worst Pruritus Numerical Rating Scale (NRS) of equal to or more than four points.
Data from the study showed that significantly higher proportion of patients receiving either dose of Rinvoq showed improvement in skin clearance and reduction in itch versus placebo at week 16. While a respective 60% and 73% of the patients receiving 15mg and 30mg of Rinvoq monotherapy achieved EASI 75, the same proportion for placebo was 13%. Moreover, the proportion of patients achieving vIGA-AD score of 0/1 in the Rinvoq arm was 39% and 52% for 15mg and 30 mg dose, respectively, compared to 5% for placebo.
Clinically meaningful reductions in itch, as measured on the NRS scale, was achieved in 42% and 60% of patients receiving 15mg and 30mg of Rinvoq, respectively, versus 9% for placebo.
Please note that the Measure Up 2 study is the second phase III study evaluating Rinvoq in AD patients. Data from this study re-affirms the safety and efficacy of Rinvoq achieved in the first phase III study in the AD program — Measure Up 1. Top-line data from the Measure Up 1 study was announced last month.
Shares of AbbVie have increased 10.5% so far this year compared with the industry’s increase of 1.7%.
Rinvoq was approved by the FDA in August and by European Medicines Agency in December last year for treating moderate-to-severe rheumatoid arthritis (RA). The company is also seeking approval for a label expansion of the drug to include adult patients with active psoriatic arthritis. The company has already submitted regulatory applications for the same in the United States and Europe.
AbbVie has a strong portfolio of inflammatory/autoimmune drugs with Humira being the lead drug. Humira generate tens of billions of dollars in sales annually, contributing almost 60% of the company’s product revenues. However, the drug is facing biosimilar competition in Europe from Amgen AMGN, Biogen BIIB and Novartis NVS, which dented the drug’s international sales significantly. Biosimilar versions of Humira are set to be launched in the U.S. market beginning 2023, which will likely hamper its sales further.
Meanwhile, AbbVie believes its new drugs, Rinvoq and Skyrizi may help offset the decline in sales of Humira going forward
Apart from AD, Rinvoq is being evaluated in several studies for other indications. The drug is also being studied for Crohn’s disease, ulcerative colitis, axial spondyloarthritis, atopic dermatitis and giant cell arteritis. The drug is set to generate global revenues to be approximately $500 million for 2020. A further label expansion will significantly boost Rinvoq’s sales in the days ahead.
AbbVie Inc. Price
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